TECNIS IOL ZLB00 (REF ZLB00U0130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474560536), received between Aug 30, 2016 and Jul 23, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019 AND LATER EXPLANTED ON (B)(6) 2019 FOR DISTANCE CORRECTION AND MECHANICAL COMPLICATION. THE PATIENT COMPLAINED OF POOR VISION, AS IF A THERE IS A FILM OVER IT. THE REPLACEMENT LENS IS A AAB00 12.5 DIOPTER AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 8814646 ↗
• InjuryDec 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZLB00 (13.0 DIOPTER) WAS EXPLANTED FROM THE LEFT EYE (OS) DUE TO THE PATIENT EXPERIENCING EXTREME HALOS, GLARE, INABILITY TO SEE OR READ AT NEAR DISTANCE, ALONG WITH THE FEAR OF DRIVING AT NIGHT BECAUSE OF THE HALOS. REPORTEDLY, THE PATIENT COULD NO LONGER PUT ON MAKE UP, READ CLEARLY, AND STATED SHE HAD TO TAKE A PHOTO OF SOMETHING AND BLOW IT UP ON HER PHONE IN ORDER TO READ IT. THE PATIENT WAS DISSATISFIED AND HAD SAFETY CONCERNS WITH DRIVING. PUNCTAL PLUGS WERE INSERTED (B)(6) 2017, IN HOPES THAT ANY DRY EYE RELATED VISUAL SYMPTOMS WOULD IMPROVE; HOWEVER, THEY DID NOT HELP. ONE (1) YEAR AFTER THE INITIAL IMPLANT, THE PATIENT WAS REFERRED TO ANOTHER SURGEON FOR EVALUATION WHERE THE LENS WAS THEN EXPLANTED AND REPLACED. VISUAL ACUITY PRE-OPERATIVE: LEFT EYE (OS): 20/25; VISUAL ACUITY POST-OPERATIVE: LEFT EYE (OS): 20/20-20/25; OS-GLARE 20/400. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8122906 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINT OF DAY AND NIGHTTIME STARBURSTS AND HALOS, WHICH HAS MADE IT DANGEROUS TO DRIVE. THE PATIENT ALSO COMPLAINT OF GLARE, ESPECIALLY WHEN DRIVING. REPORTEDLY, THE PATIENT HAS TO WEAR CHEATERS TO PERFORM UP-CLOSE WORK AND STATES HE HAS DRY EYE, BUT IS TAKING OVER THE COUNTER MEDICATION FOR THIS. THE PATIENT ALSO HAD A LASIK CONSULTATION, WHICH HE WAS ADVISED WOULD NOT HELP WITH THE CURRENT ISSUE. THE PATIENT WILL BE MEETING WITH THE SURGEON ON (B)(6) 2018 TO DISCUSS OPTIONS OF HAVING THE LENS EXCHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT''S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7338623 ↗
• InjurySep 21, 2017Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT A ZLB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017, AND LATER EXPLANTED ON (B)(6) 2017. THE LENS WAS REPLACED WITH A MODEL, ZXR00, A LARGER 16.0 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6885252 ↗
• InjurySep 11, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2017 WITH NO PATIENT INJURY. POST-OPERATIVELY, THE PATIENT ENDED UP -1.75 DIOPTERS AND AN EXPLANT IS PLANNED ON 2017 TO REPLACE THE LENS WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 10.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6854328 ↗
• InjuryNov 15, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO WRONG POWER USED. THE PATIENT SYMPTOMS WERE HALOS AND GLARE, VISUAL DISTURBANCE AND POOR VISUAL QUALITY. INCISION ENLARGEMENT WAS REQUIRED AND LENS WAS REPLACED WITH A NON-AMO LENS. PATIENT HAS NOW RECOVERED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6101344 ↗
• InjuryAug 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED GLARES AROUND LIGHT DURING NIGHT TIME AFTER IMPLANTATION OF A ZLB00 INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 5916236 ↗